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Quantitative Faecal Immunochemical Testing Automated System - HM-JACKarc

Quantitative Automated FIT System

Faecal Immunochemical Test (FIT) for Bowel Cancer Detection - Now recommended by NICE DG30

High quality measurement of faecal haemoglobin for both asymptomatic and symptomatic assessment for bowel cancer and other colorectal diseases

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In recent years, some countries have replaced the traditional guaiac based faecal occult blood tests (gFOBT) strategy for screening with Faecal Immunochemical Tests for haemoglobin (FIT), since they provide better analytical sensitivity and specificity for human haemoglobin and are superior in detection of adenomatous polyps as well as colorectal cancers (CRC).

The use of FIT in the assessment of the symptomatic is changing too, as more publications have demonstrated that the use of quantitative FIT as a “rule-out” test has benefits to clinicians, laboratories and patients.

A recently accepted article, concluded that FIT is highly accurate for the detection of CRC in symptomatic patients and was more so than the NICE (National Institute for Health and Care Excellence) and SIGN (Scottish Intercollegiate Guidelines Network) referral criteria. This work demonstrated that, when FIT with a 20 µg Hb/g faeces cut-off concentration was used instead of the NICE referral criteria, 19.6% fewer colonoscopies would have been needed to detect 42% additional CRC.

Download ‘A Tale of Two Settings’ – Distinguising FIT in Screening from FIT in Assessment of the Symptomatic

NICE DG30 Recommends FIT

Quantitative FIT (qFIT) results have demonstrated greater sensitivity for cancers and high risk adenomas than guaiac and it is accepted that increasing detection levels of faecal haemoglobin (f-Hb) are indicative of increased risk of pathology 1,2.

Currently, there are many studies, published and in progress, that examine the usefulness of measuring faecal haemoglobin quantitatively in those presenting with symptoms. In this setting, FIT could reduce the burden of colonoscopy in a similar way that calprotectin testing has, when FIT is adopted as a routine test for the symptomatic.

NICE Guidance DG30 “Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care” was published in July 2017, following evidence based reviews. This recommends quantitative faecal immunochemical tests for adoption in primary care to guide referral for suspected colorectal cancer in people without rectal bleeding who have unexplained symptoms but do not meet the criteria for a suspected cancer pathway referral outlined in NICE's guideline on suspected cancer. NICE confirms that results should be reported using a threshold of 10 micrograms of haemoglobin per gram of faeces.

The new NICE guidance states that ...

​...[FIT] assays were also cost effective when compared with no triage, with the HM-JACKarc dominating (that is, it was more effective and less expensive)"

Laboratories who embrace the newer technology of FIT can provide a more proactive service to their community whilst embracing the productivity benefits of an automated system.

Introducing Faecal Immunochemical Testing for Symptomatic Patients at Monklands Hospital, NHS Lanarkshire

Ninewells Case Study

Introducing the FIT Service at Ninewells Hospital & Medical School, NHS Tayside

Tayside Case Study

References

1. Low faecal haemoglobin concentration potentially rules out significant colorectal disease.
PJ McDonald, et al. Colorectal Dis 15 (3), e151-e159. 3 2013.

2. Diagnostic accuracy of faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria
J Cubiella, et al. Colorectal Dis. 2014 Aug;16(8):O273-82. doi: 10.1111/codi.12569

NICE DG30- The Benefits of Faecal Immunochemical Testing

5.2 The committee discussed the potential benefits that may be associated with using faecal immunochemical tests in primary care. It heard from clinical specialists that faecal immunochemical tests are thought to be more accurate than guaiac-based faecal occult blood tests because they use immunochemical detection methods that are specific to human haemoglobin.
They are also suitable for use with automated analysers, which allow high-throughput batch testing.
It also heard from a patient specialist that faecal immunochemical tests often had sample collection devices that are easier to use than guaiac-based faecal occult blood tests and they need fewer samples, which makes them more acceptable to people and so may increase test uptake.
The committee concluded that faecal immunochemical tests may have substantial analytical and practical advantages over guaiac-based faecal occult blood tests.

The Benefits of Using HM-JACKarc for Automated FIT

The HM-JACKarc system is easy to set up and can be loaded with up to 80 samples at any one time. It can stand alone or be linked to the LIS, allowing flexible options for connectivity and full audit trail of results, QC and reagent lot numbers.

Advanced Sample Collection System

  • Easy to use sample device collects a consistent sample size across different faecal matter
  • Internal septum removes excess sample
  • <2mg of sample in 2ml of buffer  (ng/ml = µg Hb / g faeces)
  • Tamper seal and window to confirm sample applied
  • Unique bar code number for the tube (lot no./expiry date/tube no.
  • Collection buffer stabilises the faecal sample haemoglobin
    • 120 days at 04°C (refrigerated)
    • 14 days at 25°C (ambient temp)

Opening_FIT_Picker

Fully Automated Instrument

  • Compact and light bench top unit with touchscreen interface
  • Uses Integrated Sphere Latex Turbidimetry to measure faecal haemoglobin concentration
  • Sensitivity: 7 ng/mL
  • Cut-off concentrations can be selected depending on requirements – Screening or Symptomatic Testing
  • No prozone effect up to 200,000 ng/mL
  • High speed performance: 200 samples/hour
    • Time to first result 5.6 minutes
    • Additional results every 18 seconds
  • Factory set Master curve with local 2 point recalibration
    • Calibrates system to local conditions and reagent combinations
    • Calibration weekly
  • System can store 2 calibration curves
    • Calibration of different lots of latex
    • Same lots with different calibrators

HM_JACKarc Technology

 HM_JACKarc_Technology

Latex Reagent

  • Provides a large concentration of capture antibodies
  • Wide dynamic range
    7ng/ml to 400 ng/ml (ng/ml = µg Hb/g faeces)
  • High Hook capacity > 200,000ng/ml
    Ensures no samples will give a falsely lower result
  • Drives reaction kinetics to end stage equilibrium quickly

HM_JACKarc_Capture_Antibody

  • 01- Focus on FIT Brochure 2017

    • PDF size: 11.25KB
    • Uploaded on: 09/05/2017

    A series on articles and case studies on Faecal Immunochemical Testing in Colorectal Cancer Pathways

    Open File
  • 02_FIT in the Symptomatic: Putting Theory into Practice

    • PDF size: 1.12MB
    • Uploaded on: 03/08/2017

    Presentations made by Experts in the Field at ACB Focus May 2017

    Open File
  • 03-FIT Case Study - NHS Lanarkshire

    • PDF size: 9.73KB
    • Uploaded on: 18/05/2017

    Introducing Faecal Immunochemical Testing for Symptomatic Patients at Monklands Hospital, NHS Lanarkshire

    Open File
  • 04- FIT Case Study - NHS Tayside

    • PDF size: 16.68KB
    • Uploaded on: 18/05/2017

    Introducing the FIT Service at Ninewells Hospital & Medical School, NHS Tayside

    Open File
  • A FIT Sample

    • PDF size: 11.85KB
    • Uploaded on: 12/09/2016

    New Faecal Immunochemical Test Systems could Improve Sample Integrity for Faecal Haemoglobin

    Open File
  • A FIT system for any Laboratory

    • PDF size: 9.65KB
    • Uploaded on: 04/04/2017

    HMJACKarc Technical Flyer

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  • A Tale of Two Settings

    • PDF size: 10.79KB
    • Uploaded on: 18/05/2017

    Distinguishing the parameters for the use of FIT in Screening from FIT in Assessment of the Symptomatic

    Open File
  • ACB FOCUS 2016 Industry Sponsored Workshop Presentations

    • PDF size: 6.70KB
    • Uploaded on: 25/04/2016

    The NICE NG12 Guidelines: A FIT Solution! - Prof. C.G. Fraser, Dr. Ian Godber, Mr Paul Skaife

    Open File
  • Diagnostics for Digestive Health Management

    • PDF size: 10.67KB
    • Uploaded on: 04/05/2017

    Open File
  • FIT for All - Screening and Symptomatic Testing for Bowel Cancer - A Single Solution

    • PDF size: 9.39KB
    • Uploaded on: 13/03/2017

    Quantitative Faecal Immunochemical Testing for Haemoglobin with Flexible Cut-off Results

    Open File
  • FIT for Purpose :

    • PDF size: 10.62KB
    • Uploaded on: 06/03/2017

    FIT systems must be sensitive and specific enough to detect f-Hb at the proposed 10µg/g cut-off level

    Open File
  • Focus on FIT - ACB Focus April 2016

    • PDF size: 10.41KB
    • Uploaded on: 18/07/2016

    Can Faecal Immunochemical Testing (FIT) Improve the Pathway for Patients with Lower GI Cancers?

    Open File
  • Fulfilling the new NICE NG12 requirements Use FIT and f-Hb – not gFOBT

    • PDF size: 799.25KB
    • Uploaded on: 15/03/2016

    Professor Callum G. Fraser, Centre for Cancer Prevention and Screening

    Open File
  • Getting FIT for the Future!

    • PDF size: 9.82KB
    • Uploaded on: 15/03/2016

    FIT for Clinicians and FIT for Patients

    Open File
  • HM-JACKarc - Ian Godber Monklands Hospital Study

    • PDF size: 10.76KB
    • Uploaded on: 18/07/2016

    Can an automated Faecal Immunochemical Test (FIT) determine whether faecal haemoglobin (f-Hb) concentrations can aid in stratifying symptomatic patients referred for colonoscopy?

    Open File
  • HM-JACKarc Automated FIT System Flyer

    • PDF size: 9.48KB
    • Uploaded on: 14/03/2016

    Open File
  • HM-JACKarc Operation Guide

    • PDF size: 10.07KB
    • Uploaded on: 13/03/2017

    Open File

FIT for Symptomatic Assessment

1. Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria. J. Cubiella et al. Colorectal Disease; Volume 16Issue 8pages O273–O282August 2014

2. Faecal Tests for Blood - Think FIT not FOB.
Scottish Cancer Prevention Network. April 2015 

3. Investigating Bowel Symptoms - Remember the Rule of the Sixths. Professor Callum G Fraser.
Scottish Cancer Prevention Network. June 2015

HM-JACKarc

Evaluations of the HM-JACKarc are underway and publications are being generated on the performance of the system in both asymptomatic screening and symptomatic assessment clinical applications.

References

1. Low faecal haemoglobin concentration potentially rules out significant colorectal disease. PJ McDonald et al. 
Colorectal Dis 15 (3), e151-e159. 

2. Diagnostic accuracy of faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria.
J Cubiella, et al. Colorectal Dis. 2014 Aug;16(8):O273-82. doi: 10.1111/codi.12569

3. A poster was presented by Ian Godber, Consultant Clinical Scientist, Clinical Lead, NHS Lanarkshire, at a workshop during the EuroLabFocus meeting in Liverpool on 8th October 2014.

This study was conducted at Monklands Hospital, where all patients undergoing a colonoscopy were asked to participate by providing a single small faecal sample, easily collected in a hygienic specimen collection device, for analysis on the HM-JACKarc system, before they underwent colonoscopy.

Download the Poster entitled; "Can an automated Faecal Immunochemical Test (FIT) determine whether faecal haemoglobin (f-Hb) concentrations can aid in stratifying symptomatic patients referred for colonoscopy".

HM-JACKarc Bibliography

HM1. Evaluation of quantitative Faecal Immunochemical Tests for haemoglobin - GMEC report Nov 2013, M Carroll et al.

Evaluates the HM-JACKarc  for technical performance for specificity, sensitivity and precision across a range of different haemoglobin concentrations when stored in specific temperatures.  Confirms the suitability of the system for the detection of haemoglobin in faecal samples

HM 2. Clinical Utility of HM-JACKarc for the Detection of Colorectal Cancer and High Risk Adenomas, JM AUGE Fradera et al., Laboratory of Biochemistry, School of Medicine, Hospital Clinic, Barcelona. Mar2014

Concludes that HM-JACK arc is easy to use and its’ analytical performance proves its suitability for use in clinical chemistry labs for early detection of colorectal cancer and high risk adenomas.

HM3. Overall evaluation of an immunological latex agglutination system for fecal occult blood testing in the colorectal cancer screening program of Florence, Tizian Rubecca, Benedetta Peruzzi, Massimo Confortini, Stefano Rapi , ISPO Florence, Careggi, Hospital, Florence 2013 
Int J Biol Markers. 2012 Oct 8;27(3):e195-202. doi: 10.5301/JBM.2012.9343.

This study compares HM-Jack with OC Sensor.

HM4. Studies on HM JACK for Fecal Occult Blood Analyser, Yutaka Nara, Noriko Harashima, Hitoshi Ikeda, Dept.of Laboratory Medicine, Saitama Medical Centre. The Saitima Journal of Medical technology 1999 vol. 46

The HM-JACK was shown to yield favourable intra and inter –day precision and accuracy,sufficient measurement range and stability of Hb after sampling.This analyser is fast and easy to use analysing 180 sample/hour.In addition ,stool sampling using piercing procedure yields good reproducibility making it a good choice for routine use.

HM5. Comparison of fecal occult blood assay by four companies.  Sayuri Nakayasu et al, Division of Laboratory, Matsuai-kai, Matsuda Hospital

Compares the clinical sensitivity and specificity of reagents for Kyowa Medex ,Wako.Fujirebio and Azwell Co.  Specificity comparison revealed that the kits of manufacturers using a high fecal concentration in the fecal sampler after sampling (i.e., final fecal concentration) tended to have a lower specificity. The important factors that impact on the sensitivity and specificity of the various kits are the determination of the cut-off value, the accuracy of fecal sampling and the characteristics of the antibody that is used.

HM 6. Evaluation of the Extel “Hemo Auto” HS and the Hemo Auto MC Feces Collection Container Using the HM-JACKarc Fully Automated Fecal Occult Human Hemoglobin Analyzer. Masahiro ITOH*1, Tsuyoshi FUKUDA*2, Go NAGAI*3 , Journal of Clinical Laboratory Instruments and Reagents, Vol. 34, No. 3 (June, 2011) – Supplement

An in house evaluation of HM-JACKarc covering specificity, sensitivity, prozone, sample stability etc.

HM 7. Faecal haemoglobin concentrations vary with sex and age but data are not transferrable across geography for colorectal cancer screening. CallumG, Fraser,Tiziana Rubeca,Stefano Rapi, Li-Sheng Chen and Hsui-Hsui Chen. CCLM2014

Suggests that individualisation of FHb is the optimum approach.

HM 8. Impact of preanalytical factors on fecal immunochemical tests;need for new strategies in comparison of methods. Tiziana Rubeca, Fillipo Cellai, Massimo Confortini, Callum G.Fraser, Stefano Rapi. IJBM2015

Suggests adoption of protocols to discriminate preanalytical and analytical variation would contribute to harmonization of FIT.

HM 9. Clinical Utility of one versus two faecal samples in the detection of advanced colorectal neoplasia in symptomatic patients. Josep Maria Auge, CallumG Fraser, Cristina Rodriguez, Alb Roset, Maria Lopez Ceron, Jaume Grau, Antoni Castells, Wladimiro Jiminez. CCLM 2015.

Undetectable FIT is a good strategy to rule out ACRN. The diagnostic yield of 2 samples can be achieved with 1 sample but a lower cut off must be used.

Alpha Laboratories has been at the forefront of faecal testing in the UK for nearly 20 years. This was initially as the market leader for guaiac-based faecal occult blood testing in hospital laboratories. Tender wins for bowel screening in all four UK countries followed this, as each launched its own screening programme, assessing the average risk asymptomatic populations.

Continuing to provide leading edge products, Alpha Laboratories has  been awarded the first contract for quantitative FIT as the front line test in the Scottish Bowel Screening Programme. This will employ the Kyowa Medex HM-JACKarc system. England will also be moving to a quantitative FIT method in the NHS Bowel Cancer Screening Programme in the near future, for which Alpha Laboratories was also successful in the tender for a framework agreement.

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